Ceftriaxone EP Impurity A

Stability Indicating Chromatographic Methods For Simultaneous Determination of Ceftriaxone Sodium and Sulbactam Sodium in their Combined Dosage Form
By EL-Bagary, Ramzia I.; Abo-talib, Nisreen F.; El-Hakeem, Maha M.; N. Eldin, M. Badawi
From Current Pharmaceutical Analysis (2018), 14(5), 461-474
 
Stability-​indicating spectrophotometric methods for determination of ceftriaxone in presence of its alkaline degradation product
By Attia, Khalid A. M.; Nassar, Mohammed W. I.; Abdul, Aziz M. M. El-Attar
From Analytical Chemistry: An Indian Journal (2016), 16(9), 398-405

Ceftriaxone EP Impurity A is chemically (6R,7R)-7-[[(2E)-(2-Aminothiazol-4-yl)(methoxyimino)acetyl]amino]-3-[[(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)sulfanyl]methyl]-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (as per EP) ; (6R,7R)-7-[(E)-2-(2-Aminothiazol-4-yl)-2-(methoxyimino)acetamido]-3-{[(6-hydroxy-2-methyl-5-oxo-2,5-dihydro-1,2,4-triazin-3-yl)thio]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (as per USP). It is also known as Ceftriaxone E-Isomer (USP). Ceftriaxone EP Impurity A is supplied with detailed characterization data compliant with regulatory guideline. Ceftriaxone EP Impurity A can be used for the analytical method development, method validation (AMV), Quality Controlled (QC) application for Abbreviated New Drug Application (ANDA) or during commercial production of Ceftriaxone.

The product can be used as reference standards and further traceability against pharmacopeial standards (USP or EP) can be provided based on feasibility. SynZeal products are for analytical purpose only and not for human use.